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Thinking Healthy Program - Peer Delivered, India (THPP-I) (THPP-I)

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ClinicalTrials.gov Identifier: NCT02104232
Recruitment Status : Completed
First Posted : April 4, 2014
Last Update Posted : August 25, 2017
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Liverpool
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Brief Summary:

Background The rates of perinatal depression in South Asian women are reported to be amongst the highest in the world, ranging from 18%-30% in urban areas and 28%-36% in rural areas. In addition to its profound impact on women's health, disability and functioning, perinatal depression is associated with poor child health outcomes such as pre-term birth, infant under-nutrition and stunting. There is robust evidence that perinatal depression can be effectively managed with psychological treatments delivered by non-specialist health care workers. The Thinking Healthy Program (THP), a psychological treatment delivered by community health workers (CHWs) in Pakistan, more than halved the rate of perinatal depression among mothers and led to significant improvements in child health outcomes. To enhance access to such evidence-based psychological treatments there is a need to examine the potential role of other human resources such as lay persons in delivering psychological treatments such as THP in poor resource settings.

Objective To evaluate the effectiveness and cost-effectiveness of THP delivered by peers (the Thinking Healthy Program-Peer delivered in Goa, India; THPP-I) over the duration of 6 months. Peers will be healthy mothers who live in the same community as potential trial participants (TPs).

Study design and outcomes Individual randomized controlled trial in Goa, India involving 280 women. TPs will not be blinded to treatment allocation. Mothers attending antenatal clinics at hospitals will be assessed for eligibility to participate in the trial (e.g. whether they are in the second or third trimester of pregnancy). Those who are eligible will be invited to participate in screening for depression; mothers who consent will be screened for depression with a locally validated version of the Patient Health Questionnaire (PHQ-9). Women who screen positive (PHQ-9 score ≥ 10) and give informed consent for further participation in the trial will be randomly allocated in a 1:1 ratio to receive enhanced usual care (EUC) or THPP-I+EUC, using a computer generated allocation sequence. The primary outcomes will be remission (i.e. recovery from depression and depressive symptoms), both assessed by the PHQ-9 at 6 months. Secondary outcomes are depressive symptoms and remission at 3 months (PHQ-9), maternal disability at 3 and 6 months (measured with the WHO-DAS), perceived social support, breastfeeding rates and infant weight and height of children at 3 and 6 months. Outcomes will be analyzed on an intention to treat basis.

Interventions EUC will comprise communicating the results of the screening to the mother through an information sheet on self-care for mental health, communicating the results to the mother's gynaecologist, providing the gynaecologist with the WHO mhGAP guidelines for the treatment of depression, and providing guidance on referral of depressed mothers to mental health services. TPs who are in the THPP-I group will receive, in addition to EUC, between 6 to 14 sessions of THPP starting from their recruitment in the second/ third trimester until up to 6 months after child birth. Sessions will be delivered by peers on an individual basis at a location of convenience to the TPs (usually at their own homes).

Implications THPP-I has the potential to advance knowledge of the extent to which task-shifting of the delivery of evidence-based psychological treatments can be extended to peers in the community. If effectiveness is observed, this approach offers a potential opportunity to access a vast untapped human resource for maternal mental health care and addresses a major barrier in global mental health - the lack of skilled and motivated human resources in the formal health sector - offering a new avenue for the scaling up of evidence-based psychological treatments and mental health services in low resourced settings.


Condition or disease Intervention/treatment Phase
Unipolar Depression Behavioral: THPP-I Behavioral: EUC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thinking Healthy Program - Peer Delivered, India (THPP-I)
Study Start Date : October 2014
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: THPP-I
TPs in the THPP-I group receive, in addition to enhanced usual care (EUC), between 6 to 14 sessions of THPP (simple cognitive behaviour therapy) starting from their recruitment in the second/ third trimester until up to 6 months after child birth. Sessions will be delivered by peers on an individual basis at a location of convenience to the TPs.
Behavioral: THPP-I
Behavioral: EUC
Enhanced usual care (EUC)
Enhanced usual care (EUC) will comprise communicating the results of the screening to the mother through an information sheet on self-care for mental health, communicating the results to the mother's gynaecologist, providing the gynaecologist with the WHO mental health gap (mhGAP) guidelines for the treatment of depression, and providing guidance on referral of depressed mothers to mental health services.
Behavioral: EUC



Primary Outcome Measures :
  1. Remission (i.e. recovery from depression) and depressive symptoms, assessed by the PHQ-9 [ Time Frame: 6 months post-child birth ]

Secondary Outcome Measures :
  1. Depressive symptoms and remission (PHQ-9) [ Time Frame: 3 months post-child birth ]
  2. Maternal disability (measured with the WHO-DAS) [ Time Frame: 3 and 6 months post-child birth ]
  3. Breastfeeding rates of women [ Time Frame: 3 and 6 months post child birth ]
  4. Infant weight [ Time Frame: 3 and 6 months post-child birth ]
  5. Infant height [ Time Frame: 3 and 6 months post child birth ]
  6. Perceived social support (measured with MSPSS) [ Time Frame: 3 and 6 months post child birth ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • In the 2nd or 3rd trimester of pregnancy
  • Aged 18 years and over
  • Intending to reside in the selected areas of the intervention delivery for the entire duration of the study (mothers intending to be away for more than 2 months during or after the period of child birth will be excluded).

Exclusion criteria:

  • Mothers requiring immediate inpatient care for any reason (medical or psychiatric)
  • Mothers who do not speak any of the following languages: Konkani, Hindi, English, Marathi
  • Mothers whose expected date of delivery is within 3 weeks of their screening date
  • Previously screened using the PHQ-9 within the last month
  • Mothers with difficulty hearing/speaking which makes the assessment difficult

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104232


Locations
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India
Sangath
Goa, India
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
National Institute of Mental Health (NIMH)
University of Liverpool
Investigators
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Principal Investigator: Vikram Patel, PhD London School of Hygiene and Tropical Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02104232     History of Changes
Other Study ID Numbers: THPP-I MH095687
1U19MH095687-01 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Keywords provided by London School of Hygiene and Tropical Medicine:
Maternal depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders